NCT04205955

Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors

A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how a diet intervention works in improving bowel dysfunction symptoms related in colon or rectal cancer survivors. Changing a diet may be helpful in reducing the severity of bowel symptoms, including diarrhea and constipation, and improve quality of life in colon or rectal cancer survivors and help doctors learn how to help patients better in the future.

Detailed description

PRIMARY OBJECTIVES: I. To compare total bowel function score, as measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI), at 18 weeks post-randomization between the intervention and attention control arms. EXPLORATORY OBJECTIVES: I. To compare total bowel function score at 26 weeks post-randomization between the intervention and attention control arms. II. To compare bowel function subscale scores (dietary, urgency, frequency), as measured by the BFI at both 18- and 26- weeks post-randomization between the intervention and attention control arms. III. To compare lower anterior resection syndrome (LARS) scores (for anastomosis participants only), quality of life, and dietary quality at both 18- and 26- weeks post-randomization between the intervention and attention control arms. IV. To compare motivation, self-efficacy, and positive/negative affect at both 18- and 26- weeks post-randomization between the intervention and attention control arms. V. To assess study feasibility, adherence, retention, and acceptability at both 18 and 26 weeks post-randomization. VI. To explore variation in primary and exploratory study outcomes according to sex, and to investigate whether intervention effects on the primary outcome differ across subgroups defined by sex. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6. ARM II: Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6. After completion of study, patients are followed up at 26 weeks.

Conditions

• Rectal Carcinoma
• Rectosigmoid Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive healthy living education via phone call
DIETARY_SUPPLEMENT	Dietary Intervention	Receive diet modification coaching via phone call
OTHER	Message	Receive motivational messages via email and/or text message
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-02-10
• Primary completion: 2023-04-01
• Completion: 2023-08-01
• First posted: 2019-12-20
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

226 sites across 2 countries: United States, Guam